I Kua na'u Advance Care Planning for Native Hawaiian Elders

NCT04771208 | Active Not Recruiting

• 2 other identifiers: H-413431R01NR018400
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Communication surrounding serious illness decision making is formalized in Advance Care Planning (ACP), a process involving verbal or written information designed to inform patients of possible medical options including palliative and hospice care services. Numerous studies have suggested that improved ACP rates better align health care delivery with patient preferences. Despite expansion of ACP services in the health care system, Native Hawaiians (NHs) consistently have negligible rates of ACP and low use of palliative and hospice care services. To address these shortcomings, our multi-disciplinary community and research group has partnered to create the I kua na'u "Let Me Carry Out Your Last Wishes" ACP video intervention. Our Community-Based Collaborative Approach will create, develop and test the I kua na'u comprehensive video-based ACP program honoring the history, opinions, and culture of NHs. Indeed, NH culture is primarily an oral tradition in which the spoken word permeates the life of NHs and is the normal way of interacting with neighbors, including in its most recent adaptation with the use of video media. The I kua na'u program will include videos tailored for the different settings in which older NHs live and get medical care. The videos will explain the importance of ACP, empower NHs to tell their story ('olelo Kama'ilio; "Talk Story") by allowing the recording of personal video declarations of ACP wishes, and the ability to share the personal video declaration with family, friends and clinicians. The overall objective is to conduct a five-year program that includes two years of development of the I kua na'u ACP video program with focus group testing, and then three years of implementation in the NH community. Demonstrating the effectiveness of using the video program in NHs represents an essential step to implement this tool in practice. The Specific Aim is to compare the ACP engagement, knowledge, decisional conflict, and ACP completion rates in 220 NHs over the age of 55 in: (a) a pre-post study design in 110 people living on Homestead or Assisted Living using the video intervention, and (b) a randomized trial of 110 people recruited from Ambulatory Clinics.

Conditions

Advance Care Planning

Keywords

medical decision making; Native Hawaiians; educational decision aid video; doctor patient communication

Outcome Measures

Primary Outcomes (2)

• Change in ACP Knowledge (Pre-Post Trial)

  Six questions regarding knowledge of ACP which were used and validated in previous studies will be asked. A score of 0-6 will be assigned. Higher scores indicate more knowledge. Questions will be asked before and after the intervention is administered.

  Baseline, 6 weeks, 3 months, 6 months

• Change in ACP Knowledge (RCT)

  Six questions regarding knowledge of ACP which were used and validated in previous studies will be asked. A score of 0-6 will be assigned. Higher scores indicate more knowledge.

  Baseline, 6 weeks, 3 months, 6 months

Secondary Outcomes (12)

• Change in End of Life Health Care Preferences (Pre-Post Trial)

  Baseline, 6 weeks, 3 months, 6 months

• Change in Decisional Conflict (Pre-Post Trial)

  Baseline, 6 weeks, 3 months, 6 months

• Change in Advance Care Planning Engagement (Pre-Post Trial)

  Baseline, 6 weeks, 3 months, 6 months

• Change in End of Life Health Care Preferences (RCT)

  Baseline, 6 weeks, 3 months, 6 months

• Change in Decisional Conflict (RCT)

  Baseline, six weeks, 3 months, 6 months

Study Arms (3)

Pre-Post Trial

OTHER

Native Hawaiian participants from Homestead and Group Assisted Living (N=110) will partake in a pre-post study design. Participants will receive a baseline survey (as described below), view the ACP video intervention, and receive a post-intervention survey, which includes the same items as the baseline survey. In-person or phone interviews will be done at three and six months.

Behavioral: I kua na'u "Let Me Carry Out Your Last Wishes"

Randomized Clinical Trial: Control Group

NO INTERVENTION

In the ambulatory clinics we will conduct a randomized controlled trial (N=110), and randomize (1:1) to either the video (intervention) or usual care (control) arm. The control group will receive usual care. All participants will have a baseline survey, be randomized to intervention or control, and receive a post-intervention survey, which includes the same items as the baseline survey. Follow-up in person or by phone interviews will be done at three and six months.

Randomized Clinical Trial: Intervention Group

EXPERIMENTAL

In the ambulatory clinics we will conduct a randomized controlled trial (N=110), and randomize (1:1) to either the video (intervention) or usual care (control) arm. The intervention group will use the ACP video decision aid. All participants will have a baseline survey, be randomized to intervention or control, and receive a post-intervention survey, which includes the same items as the baseline survey. Follow-up in person or by phone interviews will be done at three and six months.

Behavioral: I kua na'u "Let Me Carry Out Your Last Wishes"

Interventions

I kua na'u "Let Me Carry Out Your Last Wishes" BEHAVIORAL

A combination of Native Hawaiian advance care planning video decision support tool and personalized video declarations shared with providers and family members.

Pre-Post Trial; Randomized Clinical Trial: Intervention Group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NH adult \> 55 years of age;
• Pre-existing relationship with a primary care provider (PCP, minimum of two prior visits to PCP);
• Referral by collaborating community organization.

You may not qualify if:

• inability to view videos due to visual impairment (worse than 20/200 corrected);
• psychological state not appropriate for ACP discussions as determined by RA or clinician;
• cognitive impairment (≥2 errors) as assessed by the validated Short Portable Mental Status Questionnaire.

Sponsors & Collaborators

• Tufts Medical Center: lead
• University of Hawaii: collaborator
• Queen's Medical Center: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Hawaii

Honolulu, Hawaii, 96822-2234, United States

Location

Related Publications (1)

• Quintiliani LM, Kamaka M, Henault L, Antonio MCK, Sentell T, Spencer K, Akaka G, Honda LKL, Hanakeawe D, Dillard A, Kekauoha BP, Davis AD, Seitz R, Cabral HJ, Volandes A, Leimomi Mala Mau MK, Paasche-Orlow MK. I kua na'u "Let me carry out your last wishes" Clinical trial protocol to promote advance care planning among native Hawaiian populations. Contemp Clin Trials. 2023 Dec;135:107365. doi: 10.1016/j.cct.2023.107365. Epub 2023 Oct 24.

  PMID: 37884121 DERIVED

Study Officials

• Michael Paasche-Orlow, MD, MPH

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There are 2 different study designs included: 1. Pre-post study: NH participants from Homestead and Group Assisted Living (N=110) will partake in a pre-post study design. Participants will receive a baseline survey (as described below), view the ACP video intervention, and receive a post-intervention survey, which includes the same items as the baseline survey. 2. RCT: In the ambulatory clinics we will conduct a randomized controlled trial (N=110), and randomize (1:1) in blocks of 2 and 4 to either the video (intervention) or usual care (control) arm. The intervention group will use the ACP video decision aid and participants in the control group will receive usual care. All participants will have a baseline survey, be randomized to intervention or control, and receive a post-intervention survey, which includes the same items as the baseline survey.

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: February 25, 2021
• Study Start: March 16, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)